Finger stick blood test to assess postvaccination SARS‐CoV ‐2 neutralizing antibody response against variants

  1. Sing Mei Lim
  2. Hoi Lok Cheng
  3. Huan Jia
  4. Patthara Kongsuphol
  5. Bhuvaneshwari D/O Shunmuganathan
  6. Ming Wei Chen
  7. Say Yong Ng
  8. Xiaohong Gao
  9. Shuvan Prashant Turaga
  10. Sascha P. Heussler
  11. Jyoti Somani
  12. Sharmila Sengupta
  13. Dousabel M. Y. Tay
  14. Megan E. McBee
  15. Barnaby E. Young
  16. Paul A. MacAry
  17. Hadley D. Sikes
  18. Peter R. Preiser

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Abstract

There is clinical need for a quantifiable point‐of‐care (PoC) SARS‐CoV‐2 neutralizing antibody (nAb) test that is adaptable with the pandemic's changing landscape. Here, we present a rapid and semi‐quantitative nAb test that uses finger stick or venous blood to assess the nAb response of vaccinated population against wild‐type (WT), alpha, beta, gamma, and delta variant RBDs. It captures a clinically relevant range of nAb levels, and effectively differentiates prevaccination, post first dose, and post second dose vaccination samples within 10 min. The data observed against alpha, beta, gamma, and delta variants agrees with published results evaluated in established serology tests. Finally, our test revealed a substantial reduction in nAb level for beta, gamma, and delta variants between early BNT162b2 vaccination group (within 3 months) and later vaccination group (post 3 months). This test is highly suited for PoC settings and provides an insightful nAb response in a postvaccinated population.

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  1. Version published to 10.1002/btm2.10293
  2. ScreenIT

    SciScore for 10.1101/2021.11.11.21266241: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: 4.1 Study participants: Heathy adults age between 21-65 years old scheduled for Singapore national vaccination program were enrolled to the study in compliance with all relevant ethical regulations and was approved by Institutional Review Board of Nanyang Technological University (IRB-2021-04-020).
    Consent: All participants provided informed consent before participation under voluntary basis and reported with no prior SARS-CoV-2 infection at point of recruitment.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Experimental Models: Cell Lines
    SentencesResources
    Briefly, to produce SARS-CoV-2 pseudovirus, HEK293T cells at 36 ×106 cell density were transfected with 27 µg pMDLg/pRRE (Addgene, #12251), 13.5 µg pRSV-Rev (Addgene, #12253), 27 µg pTT5LnX-WHCoV-St19 (SARS-CoV2 Spike) and 54 µg pHIV-Luc-ZsGreen (Addgene, #39196) using Lipofectamine 3000 (Invitrogen, #L3000-150).
    HEK293T
    suggested: None
    The neutralization assay was performed by transferring the plasma-pseudovirus mixture to monolayered CHO-ACE2 cells (5×104 cells) in 100µL of complete medium containing DMEM/high glucose with sodium pyruvate (Gibco, #10569010), 10% FBS (Hyclone, # SV301160.03), 10% MEM Non-essential amino acids (Gibco, #1110050), 10% geneticin (Gibco, #10131035) and 10% penicillin/streptomycin (Gibco, #15400054).
    CHO-ACE2
    suggested: None
    Recombinant DNA
    SentencesResources
    Briefly, to produce SARS-CoV-2 pseudovirus, HEK293T cells at 36 ×106 cell density were transfected with 27 µg pMDLg/pRRE (Addgene, #12251), 13.5 µg pRSV-Rev (Addgene, #12253), 27 µg pTT5LnX-WHCoV-St19 (SARS-CoV2 Spike) and 54 µg pHIV-Luc-ZsGreen (Addgene, #39196) using Lipofectamine 3000 (Invitrogen, #L3000-150).
    pMDLg/pRRE
    suggested: RRID:Addgene_12251)
    pRSV-Rev
    suggested: RRID:Addgene_12253)
    pHIV-Luc-ZsGreen
    suggested: RRID:Addgene_39196)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.11.11.21266241v1 on medRxiv